MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-C3300
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The event involved clave¿ neutral connector where the customer reported that the device was unable to infuse during patient use.The customer reported that on vascular unit of hospital 3rd b they were having issues with the connector when going to infuse, it has also occurred when pump sets (luer lock) where connected, so the 1/4 turn of the connection maneuver didn¿t happen.Additional information was received stating that the connector failed to infuse when a pump set with luer lock connection was connected.There was patient involvement since they had the patient iv changed.No medication was used while using the connector.There was no delay in therapy, there was no adverse event, and no one was harmed as a result of this event.The event occurred at the end of the month of april, but specific date is unknown.There was no harm associated with this event.
Additional Manufacturer Narrative
One (1) used.List #011-c3300, clave¿ was returned for evaluation.As received an unknown white substance was observed on the top seal, however no physical anomalies or damage on the clave was observed, and no mating device was returned for evaluation.As received the sample was primed at gravity pressure and no flow was observed, once the sample was dissembled a white powdery substance was observed inside the fluid path, and the occlusion was confirmed.Complaint of no flow was able to be confirmed and replicated.The probable cause was due to a dry infusate residual trapped inside the fluid path during use.Lot history review was performed and no discrepancy, anomalies or no-nonconformance were identified that might lead the condition reported by the customer.

• Brand Name: CLAVE¿ NEUTRAL CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19464388
• Report Number: 9617594-2024-00728
• Device Sequence Number: 15328028
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 011-C3300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown